Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT01673269
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2012-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D042883', 'term': 'Choledocholithiasis'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D003137', 'term': 'Common Bile Duct Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071997', 'term': 'Blood Culture'}], 'ancestors': [{'id': 'D008828', 'term': 'Microbiological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2012-08-22', 'studyFirstSubmitQcDate': '2012-08-22', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD', 'timeFrame': '5 minutes and 30 minutes', 'description': 'To measure the frequency of bacteremia after ERCP with direct cholangioscopic examination of the CBD by obtaining blood culture 5 minutes and 30 minutes after the procedure'}], 'secondaryOutcomes': [{'measure': 'To measure the frequency of fever or sepsis after ERCP with direct cholangioscopic examination of the CBD', 'timeFrame': 'within 24 hours and one week of the procedures.', 'description': 'This outcome will be obtained by calling the patient 24 hour and 1 week after the procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ERCP', 'Direct cholangioscopic examination of the common bile duct', 'Choledocholithiasis', 'Cholangiocarcinoma', 'Benign stricture of common bile duct'], 'conditions': ['Choledocholithiasis', 'Cholangiocarcinoma', 'Benign Stricture of Common Bile Duct']}, 'referencesModule': {'references': [{'pmid': '26116469', 'type': 'DERIVED', 'citation': 'Othman MO, Guerrero R, Elhanafi S, Davis B, Hernandez J, Houle J, Mallawaarachchi I, Dwivedi AK, Zuckerman MJ. A prospective study of the risk of bacteremia in directed cholangioscopic examination of the common bile duct. Gastrointest Endosc. 2016 Jan;83(1):151-7. doi: 10.1016/j.gie.2015.05.018. Epub 2015 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'When a doctor performs Endoscopic retrograde cholangiopancreatography "ERCP" (Endoscopy to examine the bile duct) a flexible tube is inserted into the mouth and into the stomach. The tube passes beyond the stomach and into an opening in the liver called the bile duct. Another small flexible endoscope is inserted inside the ERCP scope to directly visualize the bile duct to ensure that there are no cancers or stones in the bile duct and occasionally to take a sample from the bile duct. The purpose of our study is to examine wither performing this procedure can transmit bacteria from the bile duct to the main blood stream.', 'detailedDescription': 'This is a prospective study to measure the frequency of bacteremia in patients undergoing ERCP with direct cholangioscopic examination of the Common Bile Duct "CBD". A blood culture will be drawn from patients prior to the procedure, 5 minutes after the procedure and 30 minutes after the procedure. The patient will be followed up for 7 days after procedure for fever and sepsis. The estimated sample size is 60 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct to ensure the clearance of the common bile duct from stones.\n\n 2- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct for stone removal.\n\n 3- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct for tissue acquisition from the common bile duct mass.\n\n 4- Adult patients (18-80) who are undergoing ERCP with direct cholangioscopic examination of the common bile duct for tissue acquisition from common bile duct strictures.\n\nExclusion Criteria:\n\n* 1- Patients younger than 18 yrs old or older than 80 yrs. 2- Pregnant patients. 3- Patient with ascending cholangitis, pneumonia or urinary tract infection 4- Patients who received antibiotics in the last 2 weeks prior to the procedure.'}, 'identificationModule': {'nctId': 'NCT01673269', 'briefTitle': 'Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University Health Sciences Center, El Paso'}, 'officialTitle': 'Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD', 'orgStudyIdInfo': {'id': 'E12053-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERCP with direct examination of the CBD', 'interventionNames': ['Other: Blood culture ( aerobic and anaerobic)']}], 'interventions': [{'name': 'Blood culture ( aerobic and anaerobic)', 'type': 'OTHER', 'description': 'Blood culture 5 minutes and 30 minutes after the procedure', 'armGroupLabels': ['ERCP with direct examination of the CBD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center at El Paso', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}], 'overallOfficials': [{'name': 'Mohamed O Othman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Tech University at El Paso'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University Health Sciences Center, El Paso', 'class': 'OTHER'}, 'collaborators': [{'name': 'American College of Gastroenterology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mohamed O Othman', 'investigatorAffiliation': 'Texas Tech University Health Sciences Center, El Paso'}}}}